As a component of a comprehensive management program for topical treatment in immunocompetent patients with mild to moderate onychomycosis of fingernails and toenails without lunula involvement, caused by T. rubrum .

Contraindications

Hypersensitivity to any component.

Dosage and Administration

ShampooAdults and children 16 y and older

Topical Wet hair and apply approximately 5 mL to the scalp. Up to 10 mL may be used for long hair. Lather and leave on hair and scalp for 3 min. Rinse off. Repeat treatment 2 times/wk for 4 wk, with a minimum of 3 days between applications. If no improvement after 4 wk of treatment, reevaluate the diagnosis.

Cream/suspensionAdults and children 10 y and older

Topical Gently massage cream into the affected and surrounding skin areas twice daily, morning and evening. If no improvement after 4 wk of treatment, reevaluate the diagnosis.

Topical Apply every day, at bedtime or 8 h before washing, to all affected nails with the provided applicator. Apply evenly over the entire nail plate. If possible, apply to nail bed, hyponychium, and the under surface of the nail plate when it is free of the nail bed (eg, onycholysis). Do not remove product on a daily basis. Make daily applications over the previous coat and remove with alcohol every 7 days, repeating this cycle throughout the duration of therapy. As a comprehensive management program for onychomycosis, removal of the unattached, infected nail, as frequently as monthly, by a health care professional, weekly trimming by the patient, and daily application of the medication are integral parts of therapy.

General Advice

For topical use only. Not for ophthalmic, otic, oral, or intravaginal use.

Do not use occlusive wraps or dressings on treated areas.

Storage/Stability

Store at 59° to 86°F. Discard any unused shampoo 8 wk after opening. Protect solution from light and away from heat and flame. Keep solution tightly capped and stored in original carton after each use.

Assess the skin or nails, as appropriate, and identify areas where medication is to be applied. Assess and document skin or nail condition before initial application and periodically throughout treatment.

Pregnancy

Category B .

Lactation

Undetermined.

Children

Shampoo/gel

Safety and efficacy not established in children younger than 16 y of age.

Cream/suspension

Safety and efficacy not established in children younger than 10 y of age.

Inform patient that a sensation of burning or stinging may be felt shortly after application of the gel and that this is expected and should be of no concern.

Caution patient to avoid using occlusive dressings or wraps following application of cream, gel, or suspension.

Teach patient proper technique for applying shampoo: wet hair; apply approximately 1 tsp (up to 2 tsp for long hair) of shampoo to scalp; lather and leave on hair and scalp for 3 min then rinse hair and scalp. Avoid contact with eyes; if contact occurs, rinse thoroughly with water.

Teach patient proper technique for applying topical solution: review Patient Information and Instructions sheet provided with medication; wash hands; apply small amount of solution to affected nails and skin immediately surrounding the treated nails using applicator brush supplied with bottle; apply solution under surface of nail when it is free of the nail bed; daily applications should be made over the previous coat and then removed with alcohol every 7 days following which the nails should be trimmed and loose nail material filed away with emery board. The cycle is then repeated. Professional removal of unattached infected nails should be performed as frequently as monthly by health care provider.

Caution diabetic patient using solution to talk with health care provider before trimming or removing any nail material.

Advise patient using solution on nails not to use nail polish or other nail cosmetic products on treated nails.

Caution patient using solution to avoid use near open flame because product is flammable.

Advise patient that if application site of any of these products shows signs of increased irritation (eg, redness, itching, burning, blistering, swelling, oozing) to stop using the medication and contact health care provider.

Advise patient that follow-up visits to examine the skin or nail lesions may be necessary and to keep appointments.